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Articles from 2002 In November


Tabletop Heat Sealer Fitted with Quick-Change Tooling

Originally Published MPMN November 2002

EQUIPMENT NEWS: Welding and Sealing

Tabletop Heat Sealer Fitted with Quick-Change Tooling
A tabletop heat sealer includes controls and components that facilitate validation protocol setup.

A tabletop heat sealer designed for medical device, clinical trial, and pharmaceutical applications features a single-sided aluminum-roller shuttle tray with locating pins to accommodate quick-change-style seal tools. The machine is designed by Zed Industries for the production of packaging that uses thermoformed trays with Tyvek lidstock, carded pill packs, unit doses, foil lids, and conventional carded blister packs. Standard features include controls, components, and peripherals that can help to establish validation protocols and ensure repeatability.

For volume production requiring automatic card, blister, or product feeders, the company offers an in-line heat sealer with a conveyor system. Features include a precision indexing electric-motor chain drive, four-post heat-seal press, and touch screen interface. The unit is available in several sizes and lengths, and with numerous custom options to meet a range of applications.

Zed Industries, 3580 Lightner Rd., Vandalia, OH 45377.


An Affordable Ultrasonic Generator Meets Current and Future Needs

The generator's Plug-and-Weld system recognizes modules as they are added or removed and automatically reconfigures the user interface accordingly.

An affordable ultrasonic generator features time and energy welding, a four-line LCD, and a modular design that lets users install additional modules as needed. The DPC II Plus generator from Dukane Corp. includes the Plug-and-Weld system, which recognizes modules as they are added or removed from the system and automatically reconfigures the user interface. New hot keys provide one-step access to frequently used commands.

A timer module that can store up to eight setup files controls weld, hold, and after-burst times; energy-mode welding is controlled by a power signal module. A multipoint control module is available as an option.

The heavy-duty chassis has a flow-through cooling tunnel to enhance reliability. A universal power supply automatically switches from 95–130 to 190–260 V ac, and the generators are available in 100–2200-W power ranges covering the 20–70-kHz frequency range.

The company also recently introduced a 30-kHz ultrasonic welding system for applications that require greater amplitude and power than can be supplied by conventional 40-kHz systems, yet are too delicate for 20-kHz welders. It provides up to 1500 W of power, and is available in probe and press-and-thrust configurations.

Dukane Corp., 2900 Dukane Dr., St. Charles, IL 60174.


Power Supply Combines Plasma and TIG Welding

Suited for manual or automated welding, a plasma and TIG power supply can store as many as 100 weld sequences.

Up to 100 weld sequences can be programmed in a power supply that offers the flexibility of plasma or tungsten inert gas (TIG) welding. Because it can store so many weld sequences, the fully transistorized PlasmaFix P+T power supply from Process Welding Systems Inc. ensures consistent repeatability of welding parameters. Welding ranges are 0.1–50 A for plasma at a 100% duty cycle, and 0.8–50 A for TIG at a 60% duty cycle using a soft-arc start.

The power supply can be used for manual welding with a foot pedal or in automated applications with a positioning device or similar external component.

The company offers a number of welding units and accessories to automate in-place processes. In addition to power supplies, positioning devices, weld controllers, plasma torches, and standard and custom tips are available. Technical support and custom system designs are offered.

Process Welding Systems Inc., 72 Buchanan St., LaVergne, TN 37086.


Heat Sealer Meets FDA Guidelines

Advanced air-flow and process controls are built into a heat sealer to ensure reliable and repeatable performance.

A hot-air band sealer with validation features has been designed to comply with FDA guidelines. The OK Medicalbandsealer seals numerous packaging materials typically used by the medical device industry, including noncoated and coated Tyvek, laminated foil, metalized foil bags, paper and plastic combinations, and a range of polymers.

The unit designed by OK International Corp. has a stainless-steel construction and advanced air-flow and process controls to ensure continuous-duty performance in demanding applications.

The company also offers a hot-air continuous sealer with high heat capacity for the high-speed processing of thick bags. Setup and adjustment procedures have been simplified. The OK Supersealer HT has the same construction and process features as the medical-grade band sealer.

OK International Corp., 73 Bartlett St., Marlborough, MA 01752.


Laser Units Can Spot and Seam Weld

Turnkey laser welding systems are designed for prototype and small-quantity production use. Suited for processing medical components, the Universal Workstation series attains spot sizes down to 50 µm and features optimized pulse-to-pulse stability. The laser workstations are routinely used for spot- and seam-welding operations involving pacemakers, contact wires, and defibrillators. Available with up to 4 axes, the workstations can be integrated with a wide range of the company's lasers and optical configurations. Rofin-Sinar, Inc., 40984 Concept Dr., Plymouth, MI 48170.


Form-Fill-Seal System Comes with Validation Package

Speed and single-point pressure during operation, and process setup can be monitored on a form-fill-seal system's touch screen.

A horizontal form-fill-seal system designed for the medical device and pharmaceutical industries produces packages with tight sterile seals. Suited for packaging catheters, syringes, sutures, swabs, and related devices, the Integri-Seal machine from Circle Packaging Machinery Inc. features a touch screen–operated seal-validation system. It enables users to monitor speed and single-point pressure during normal operation and at process setup.

The system is offered in a single- or dual-lane configuration. Quick changeovers, single-point temperature and pressure control, and a long-dwell traveling cross-seal with touch screen temperature control are among the features. Operation parameters with date and time identification can be printed out.

Circle Packaging Machinery Inc., 3354 S. Ridge Rd., Green Bay, WI 54304.

Copyright ©2002 Medical Product Manufacturing News

Makers of Complex Components Benefit from Simple Solutions

Originally Published MPMN November 2002

HOTLINE

Makers of Complex Components Benefit from Simple Solutions

Prototyping aids in forming ceramic and metal parts

The manufacture of complex parts doesn't have to be a complex process. A company that designs and produces intricate metal and ceramic components has a unique way of forming parts that couldn't be made by using traditional techniques. Cam-Lem Inc. (Cleveland) offers a direct-manufacture process ideal for creating small quantities of complex ceramic and metal components in short amounts of time. Read more...

 

Switches Operate through Walls

Units can be used in hazardous environments

Switches, which can be either rotary or push-button, can be mounted horizontally or vertically on one side of a panel with the control electronics on the other side. Their mechanism allows the switches to work through plastics, marble, wood, glass, sheet stainless steel, and granite, explains Richard Chatham, managing director of Herga Electric (Bury St. Edmunds, Suffolk, UK). Read more...

 

Crimping Machine Designed to Process Coated Stents

Equipment resolves contamination and product defect issues

To eliminate what it considers to be drawbacks in existing stent-crimping equipment that may damage coatings, Fortimedix (Nuth, Netherlands) has developed a device that includes a number of features designed to protect coated stents. The Coated Stent Crimper was introduced at the MEDTEC Ireland Conference & Tabletop Exposition held in Galway, Ireland, in September. Read more...

Copyright ©2002 Medical Product Manufacturing News

Makers of Complex Components Benefit from Simple Solutions

Originally Published MPMN November 2002

HOTLINE

Makers of Complex Components Benefit from Simple Solutions

Prototyping aids in forming ceramic and metal parts

Intricate ceramic components such as this one can be manufactured quickly and cost-effectively by Cam-Lem Inc.

The manufacture of complex parts doesn't have to be a complex process. A company that designs and produces intricate metal and ceramic components has a unique way of forming parts that couldn't be made by using traditional techniques.

Cam-Lem Inc. (Cleveland) offers a direct-manufacture process ideal for creating small quantities of complex ceramic and metal components in short amounts of time. Parts are crafted from 3-D computer models using ceramic or metal powders. With the help of a temporary plastic binder substance, the materials are easy to form, cut, and merge into complex shapes. They can be converted overnight into solid, leak-free ceramic or metal units by simply removing the binder and consolidating the powder by sintering.

Cam-Lem has developed intricate components for clients, including a metal manifold that contains 4500 channels inside a 75 x 75 x 19-mm block, and a high-temperature flow nozzle created by laser cutting and laminating thin sheets of ceramic tape. "Components that incorporate very small internal features can be made with our methods, without the potential for failures and contamination associated with seals and adhesives," says Brian Mathewson, Cam-Lem's chief operating officer. The company's prototyping capabilities also save clients time and money.

One of the greatest benefits of this prototype manufacturing service is its rapid testing and evaluation cycles that allow companies to obtain feedback on a new design's performance. "In medical applications, it is very difficult to predict how a given design will perform," says Mathewson. "We provide testable, functional ceramic and metal prototypes with mechanical properties virtually equivalent to production devices."

Allowing designers the freedom to create, Cam-Lem touts the flexibility it offers clients. "Our unique fabrication process provides design freedom in developing components that are complex, are difficult to manufacture, or manipulate fluids and gases internally, such as in biomedical sensors or analytical instrumentation," says Mathewson. "We make it possible to invent new kinds of solutions to difficult manufacturing and design problems," he adds.

Elaine Paoloni

Cam-Lem, 1768 E. 25th St., Cleveland, OH 44114; phone: +1 216 3917750; fax: +1 216 5799225; contact: Brian Mathewson; e-mail: bbm@camlem.com; www.camlem.com

Copyright ©2002 Medical Product Manufacturing News

Switches Operate through Walls

Originally Published MPMN November 2002

HOTLINE

Switches Operate through Walls

Units can be used in hazardous environments

Magnetoresistive technology enables switches to work on either side of a wall without the need to drill holes.

Switches, which can be either rotary or push-button, can be mounted horizontally or vertically on one side of a panel with the control electronics on the other side. Their mechanism allows the switches to work through plastics, marble, wood, glass, sheet stainless steel, and granite, explains Richard Chatham, managing director of Herga Electric (Bury St. Edmunds, Suffolk, UK).

Herga's Freemount Top switches make use of giant magnetoresistive technology and can accommodate various substrate thicknesses. Because their actuators are entirely passive, the switches are suitable for use in hazardous environments or in situations where EMC issues are a concern. "This system also avoids problems with sealing, as there are no holes that have to be made in the panel," says Chatham.

According to Chatham, the advantages of this switching technology include security (the button can be removed when not in use) and self-calibration, so a new switch does not have to be custom made for every application. He adds that other functions, such as timers, can also be incorporated into the switches.

Further advantages of the Freemount Top switches include easy installation using self-adhesive mounts, and resistance to most liquids and gases. The switches can also be custom labeled to carry the name or logo of the product being controlled.

Although the components are very new to the market, Chatham imagines they will find applications in the medical sector, perhaps in control panels. "But the best bit of this is not quite knowing where they're going to sell," he admits.

Although Herga is active as a supplier in several industrial sectors, the company does a good portion of its work in the medical field. "We're able to customize our products, and the medical world likes that," says Chatham.

Benjamin Lichtman

Herga Electric Ltd., Northern Way, Bury St., Edmunds, Suffolk UK IP32 6NN; phone: +44 1284 701422; fax: +44 1284 753112; info@herga.com; http://www.herga.com

Copyright ©2002 Medical Product Manufacturing News

Crimping Machine Designed to Process Coated Stents

Originally Published MPMN November 2002

HOTLINE

Crimping Machine Designed to Process Coated Stents

Equipment resolves contamination and product defect issues

Noncontact stent crimping equipment introduced by Netherlands-based Fortimedix is designed to process coated stents without leaving tool marks or otherwise damaging the coatings.

To eliminate what it considers to be drawbacks in existing stent-crimping equipment that may damage coatings, Fortimedix (Nuth, Netherlands) has developed a device that includes a number of features designed to protect coated stents. The Coated Stent Crimper was introduced at the MEDTEC Ireland Conference & Tabletop Exposition held in Galway, Ireland, in September.

As coated stents become more widely used, it is time to address contamination and product defect issues associated with traditional crimpers, says general manager Marc van de Graaf. Users may be faced with "contamination issues, requiring them to clean indenters and other components more frequently," he says. "And the equipment may damage the coatings or leave tool marks, especially when it is used to process soft polymer carriers." To resolve these concerns, Fortimedix has developed a cartridge that protects the stent during the positioning and crimping process.

"The stent's movement through the machine is a noncontact operation," says manager of sales and marketing Henk Meens. "And during the crimping phase, a vacuum-activated sleeve inserted between the stent and the indenters protects the coating," he adds.

The sleeve can be easily replaced to accommodate various coating formulations. Henk adds that stents of different diameters and lengths can be processed without changing the tooling. The machine is also suitable for use with grafted and noncoated stents.

In addition to the safeguards designed to protect coated stents, the machine incorporates all of the features of the company's popular Universal Stent Crimper. The PLC-driven equipment promises high yields and short cycle times. The technology is based on a force-control principle: crimping continues until an equilibrium of forces is achieved. Precrimped profile measurements, tool changes, and adjustments are not required during normal operation.

The company offers a range of related equipment suited for stent manufacturing. Its Stent Pre-Reduction Machine enables the reduction of stent diameters prior to crimping to obtain optimal stent-to-balloon diameter ratios. It has also developed a heat-set machine for postcrimping operations. The machine reportedly enables users who have adopted direct stenting manufacturing practices to achieve improved stent retention, edge protection, and profile smoothness.

Norbert Sparrow

Fortimedix B.V., Horselstraat 1, 6361 HC Nuth, Netherlands; phone : +31 45 5449520; fax : +31 45 5449525; e-mail: meens@fortimedix.com; Internet: www.fortimedix.com.

Copyright ©2002 Medical Product Manufacturing News

Bluetooth-Enabled Pulse Oximeter Is Only the Beginning

Originally Published MPMN November 2002

INDUSTRY NEWS

Bluetooth-Enabled Pulse Oximeter Is Only the Beginning

Elaine Paoloni

The constricting wires of current monitoring devices are a hindrance to both patients and caregivers. In an effort to eliminate such obstacles, Nonin Medical Inc. and Penell a/s are developing the first Bluetooth-enabled pulse oximeter, which wirelessly transfers data from a sensor to a freestanding monitor.

Bluetooth wireless technology has found an important niche in the medical device industry. Although its initial goal was simply to improve personal communications systems such as cell phones and laptops, the wireless innovation today is streamlining healthcare procedures such as medical monitoring.

One of its latest applications is the first Bluetooth-enabled pulse oximeter, currently in development by Nonin Medical Inc. (Minneapolis) and Penell a/s (Hadsund, Denmark). The pulse oximeter, which measures blood oxygen saturation, merely requires that a sensor be attached to the fingertip of the patient being monitored. The technology then wirelessly transmits the information to a freestanding monitor up to 10 meters away. This eliminates unwieldy cables, allowing patients to walk around freely or to shift position in bed.

"Our aim is to further improve the flexibility of our technology, simplify the job for the healthcare provider, and add to the comfort of patients being monitored," says Gary Tschautscher, chief executive officer of Nonin.

But the pulse oximeter, scheduled to reach the market next year, is more than just a cutting-edge product for Nonin. Its technological capabilities are ready to be parlayed into expanding the company's OEM business. Nonin is prepared to offer wireless pulse oximetry to other manufacturers for integration into more-complex monitoring devices that measure blood oxygen saturation as only one of several parameters. "The future will bring new devices for patient monitoring in areas and situations not yet imagined," says Tschautscher.

Penell is also looking beyond the pulse oximeter, working with companies—such as Nonin—eager to employ a technology full of possibilities. It is currently working on a project to send data from a small but high-volume healthcare product, via a Bluetooth-enabled mobile phone, to a data server on the Internet. The project is expected to be completed in 10–16 months.

"Bluetooth makes it possible for new devices, like [the] pulse oximeter, to operate seamlessly with different types of products, such as PDAs, PCs, cellular phones, and wireless networks based on Bluetooth," remarks Bjarne Flou, chief executive officer of Penell a/s. Demonstrating the scope of Bluetooth's potential, Penell also is developing a trial product that wirelessly transfers diagnostic data in an intensive care unit from a battery-operated medical device to a Bluetooth access point, and then directly to an electronic patient record (EPR), according to Flou.

Furthermore, the company is introducing a design-in solution at Medica 2002 in Düsseldorf, Germany. It will be able to transmit data using Bluetooth from a battery-operated device to a server via a wireless local network, or through a Bluetooth-enabled mobile phone over the Internet to the server. "Using this technology, a number of portable devices can give input directly to the EPR or offer similar benefits where diagnostic data are shared on-line," explains Flou.

Although it took three years for Bluetooth technology to reach the marketplace, it now seems that its basic function—cable replacement—has been achieved. "The price is dropping rapidly, and we are already facing solutions below the $5 limit, although they are simple ones in large quantities," Flou says.

Still, some questions about Bluetooth remain, such as how vastly the healthcare market will implement the technology and how deep the penetration will be. Another unknown factor is when the next version of the technology will be introduced. As of now, Version 1.1 is the standard, with a Version 2.0 still years away, the creators of Bluetooth inform. They promise that Version 2.0 and subsequent standards will be backward-compatible to Version 1.1, encouraging product developers—who have been delaying introductions for fear that a newer version was just around the corner—to start launching Bluetooth products.

Despite such lingering uncertainties, Bluetooth—named after the tenth-century Danish Viking king Harald "Bluetooth" Blatand—is already well accepted. It is a safe and reliable technology, as it encrypts and retransmits data. Another benefit is its frequency hopping, which guards against interference. Finally, Bluetooth is competitive in cost, Flou explains, because it will be a high-volume technology.

"Bluetooth wireless technology is set to become commonly used in healthcare and medical devices," predicts Flou. Like its namesake who unified the people of Denmark and Norway, the technology is in a position to transform the world of healthcare.

Copyright ©2002 Medical Product Manufacturing News

Extrusion Process Eliminates Separate Distal Tip in Tapered Guidewires

Originally Published MPMN November 2002

INDUSTRY NEWS

Extrusion Process Eliminates Separate Distal Tip in Tapered Guidewires

Zachary Turke

Developed by EJS Extrusion LLC (Jaffrey, NH; www. ejs-extrusion.com), an extrusion process for coating discrete lengths of tapered guidewires eliminates the need for a separate distal tip. Coating the component with a polymer layer that can be consistently controlled in diameter, this process allows the company to effectively shape the distal end of the wire without requiring a separate component. A variety of medical-grade radiopaque elastomers can be used in the process to suit specific flexural and opacity requirements. Founded by MicroSpec Corp. (Jaffrey, NH.; www.microspecorporation.com) president Tom Steele, EJS Extrusion was established to commercialize this patented coating method. In addition to producing coated guidewires, the MicroSpec affiliate also licenses the coating technology to qualified partners and develops custom extrusion concepts.

Copyright ©2002 Medical Product Manufacturing News

Rapid Prototyping Provides Clearer Picture

Originally Published MPMN November 2002

INDUSTRY NEWS

Rapid Prototyping Provides Clearer Picture

Elaine Paoloni

Objet Geometries' QuadraTempo RP system, which uses the company's PolyJet process, produced this prototype of a skull with crisscrossed blood vessels. The intricate 3-D model aided doctors in separating twins conjoined at the head.

When 2-D images weren't an adequate solution to help separate conjoined twins in a Los Angeles hospital recently, medical professionals turned to the QuadraTempo rapid prototyping system by Objet Geometries (Rehovot, Israel; www. objet.co.il). Joined at the head, the Guatemalan twins had blood vessels that were intertwined, making it almost impossible to use 2-D x-rays as a guide. Facing a challenging and delicate operation, doctors believed a 3-D rapid prototyping system would work best to allow plastic surgeons to practice rerouting the blood supply and grafting skin to cover the separated brains.

Biomedical Modeling Inc. (Boston; www.biomodel.com), a rapid prototyping system fabricator for medical applications, combined three CT scans of the twins at different angles to create a single 3-D model. The company used MIMICs software from Materialise (Ann Arbor, MI; www.materialise. com) to merge the scans and process the data. The services of InterPRO (Deep River, CT; www.interpro-rtc.com/) were then sought to produce the actual prototypes.

A rapid prototyping service bureau, InterPRO built the models with QuadraTempo. The system uses Objet Geometries' PolyJet process, which creates parts by jetting the company's proprietary photopolymer materials in 20-µm layers, curing each layer with ultraviolet light immediately after it is deposited. A second, gel-like photopolymer material is used for support, and is later easily removable by water jets.

"The QuadraTempo's ability to build the delicate features without support structures allowed us to clean the models much more easily after printing them," says InterPRO coowner Kevin Dyer. "The fine details in the Tempo models proved especially critical to achieving success, since the surgeons needed to look inside the model and plan the rerouting of the blood vessels."

The PolyJet process's high resolution, 0.0008-in. layers, and features as small as 0.002 in. produce fine detail and smooth surface characteristics without labor-intensive sanding and finishing operations. The elimination of complicated postprocessing and the benefit of fast build times enable clients to deliver high-resolution prototypes faster and at a lower cost than competing technologies, according to the company.

"The design and product engineers who use such prototypes can analyze and evaluate different situations, permit better planning, enable trial- and-error of real-life actions, and immediately improve the diagnostic process," says Hanan Yosefi, CEO of Objet Geometries. "Only then will they make all necessary adjustments, before they move into the mass-production process. Imagine how much more cost-effective it is to find a defect or error at the prototype stage, rather than finding it at the mass-production stage."

The company's PolyJet process is now available on-line at www.atirapid.com. Powered by the rapid prototyping service bureau Accelerated Technologies Inc. (Erlanger, KY), the site provides instant quoting for 3-D printed rapid prototypes. Customers can submit files for printing or jetting and receive price quotes and production-time information over the Internet.

Copyright ©2002 Medical Product Manufacturing News

Pumps and Valves Highlight Size and Accuracy

Originally Published MPMN November 2002

PRODUCT UPDATE

Pumps and Valves Highlight Size and Accuracy

Suppliers introduce small and easy to use products

Zachary Turke

The need to accurately control the transport of gases and fluids is an important consideration in the design of many medical devices. To help meet this requirement, suppliers are constantly introducing new pump and valve technologies that offer OEMs increased functionality. From enhanced reliability and accuracy to smaller size and lower maintenance requirements, these components make it possible to meet almost any manufacturing requirement. Following are a few examples of recent pump and valve developments that may be of particular interest to our readers.

For further information on these and other products, please see the Buyers Guide directory of pump and valve suppliers.

Isolation valve reduces system media volume

The Model 218 valve from Quality Valve & Components allows OEMs to reduce plumbing lengths and simplify flow-path configuration.
(click to enlarge)

An inert two-way isolation valve minimizes space requirements to increase design freedom and limit the required volume of system media. Supplied by Quality Valve & Components, the Model 218 microminiature valve measures 1 in. long by 3/8 in. in diam, and requires no locating pins or other hardware for manifold mounting. "Many of the reagents used by our customers are very expensive," explains sales and marketing director Jason Kellenberger. "This valve's space-saving design allows OEMs to reduce plumbing lengths and simplify flow-path configurations to limit the amount of raw materials required to fill a system." According to Kellenberger, the component features an internal volume of 12 µl.

Offering chemical resistance for transmitting corrosive fluids and gases, the solenoid-operated valve is constructed with a Teflon diaphragm and polyetheretherketone (PEEK) body. The component delivers 35 ml/min of water at a pressure of 10 psi, and is available with a standard 24-V, 1.2-W power configuration. A 24-V, 0.5-W version is also available for continuous-duty applications that experience a maximum temperature rise of 35°C. Potential applications include portable drug dispensers, air samplers, and other handheld medical devices.

Gear pump compensates for wear

Supplied by Micropump Inc., a gear pump uses a suction shoe to prevent flow from decreasing at high outlet pressures.
(click to enlarge)

A gear pump from Micropump Inc. features a suction shoe design that compensates for wear and thermal expansion in continuous-metering applications that require maintaining accuracy over time. Offered in four standard gear sizes, the Series 180 pump uses discharge pressure to keep the suction shoe seated tightly on top of the gears to prevent flow from decreasing at higher outlet pressures. "This design also forces the gears and suction shoe to wear at the same rate, maintaining the same clearances over time," says marketing manager Jim Roberts.

In addition to enhanced durability, the Series 180 pump is constructed with fewer parts than previous models to minimize maintenance requirements. Available with helical gears that accommodate a range of temperatures, the pump provides pulseless flows at rates as low as 1 ml/min. The unit's magnetic drive and single seal keep the fluid securely inside the pump and prevent contamination. Constructed of stainless steel and engineered plastics, the pump is compatible with a variety of chemicals.

Potential applications for the pump include hemodialysis and laboratory equipment. The company can customize the component to meet individual requirements by altering construction materials, gear size, and mounting configurations.

Butterfly valves use solenoids to reduce space requirements

Two- and three-way butterfly valves from Aerodyne Controls employ rotary solenoids and brushless dc motors to reduce space requirements without sacrificing performance. "Because our valves use solenoids to provide isolation and throttling actuation, they're about half the size of valves that use other actuators," says sales manager Steven Pauly. "This design allows OEMs to design their products with much higher flow rates without increasing overall device size," he adds. Other benefits of the solenoid design include the increased reliability that results from a reduction in parts.

The valves are custom produced to customer specifications to meet strict dimensional and functionality requirements. Suited for high-reliability OEM applications, the components are available in diameter sizes of 1 to 4 in. Constructed to increase seal tightness and minimize pressure drop, the valves are available with a control system that modulates flow in response to a control signal. Current requirements can be as low as 28 V depending upon the application.

Solenoid pump suited for microdispensing

Expanding its line of self-priming solenoid-actuated microdispense pumps, Bio-Chem Valve Inc. now offers a unit capable of dispensing 8 to 250 µl of fluid per stroke. Suited for use in reagent dispensers, diluters, and draining devices, the pump features a factory-set output that allows repeatable dispensing rates of up to 200 dispenses per minute. An inert nonmetallic fluid path accommodates high-purity and aggressive fluids. Other product benefits include positive shutoff and low internal volume and power consumption.

As part of the Quick-Change Customization program, the company will modify the pump to meet a customer's application-specific needs. "To participate in the program, a client simply contacts us and tells us how the pump is going to be used," explains marketing coordinator Gary Gaetano. "Based on the application, we can modify the pump's manifold mounting configuration, orifice size, and connection specifications." A choice of plastics is also offered for construction of the pump's wetted parts.

Extended life is key feature of dispense valve

Supplied by Sealant Equipment & Engineering Inc., a tip-seal dispense valve is equipped with severe-duty components to extend unit life. Suited for use with aggressive materials, the 2200-245-series Kiss valve features abrasion-resistant seals and carbide-hardened needle and nozzle assemblies. "This valve doesn't contain a lot of soft goods," explains inside sales coordinator Paul Shafer. "And because it's mostly metal, it can accommodate fluids that range in consistency from water to thick pastes at very high pressures," he says.

In addition to sturdy components, the air-operated Kiss valve also features a nonrestrictive internal design that increases flow rates. According to Shafer, this modification translates into decreased downtime and maintenance costs. Other unit features include a stainless-steel spring that ensures shutoff if air pressure is lost.

Suited for the automated application of adhesives, sealants, silicones, urethanes, and other moisture-sensitive products, the valves can be modified to dispense materials in amounts ranging from beads to sprays. The valve features numerous drill-throughs and locator holes to accommodate manual, fixtured, and robotic applications.

Direct-acting solenoid valve offers high flow rates

A direct-acting solenoid valve from Humphrey Products Inc. offers a flow- rate coefficient of variation of 0.42 in a package that is 19 mm wide. According to company sources, the flow rate of the 315/415-series valve is 35% higher than those of similarly sized poppet valves. "In part, this elevated flow rate is enabled by the valve's patented lip-seal design that uses air pressure within the component to assist the spring in creating a tight seal," says representative Rich McDonnell. "Because it creates a positive seal, this feature also prevents contamination."

Featuring 1/8-in. NPT ports, the 315/415 valve withstands operating pressures to 125 psig. The component is offered with a 5-W coil and a variety of ac and dc voltage options. Designed for both in-line and manifold mounting, the valve is supplied with an optional sandwich speed control that mounts between the valve and the manifold. Potential product applications include oxygen concentrators and nebulizers.

Copyright ©2002 Medical Product Manufacturing News

Fiber-Optic Probe at the Heart of MRI-Safe Pacemaker

Originally Published MPMN November 2002

PROFILE

Fiber-Optic Probe at the Heart of MRI-Safe Pacemaker

Probe tip is similar in size to pacemaker leads that it replaces

By replacing metal leads in its pacemakers with a fiber-optic cable, Biophan developed an MRI-safe device.
(click to enlarge)

In 1997, FDA published a draft document recommending that individuals with implanted pacemakers should not enter magnetic resonance imaging (MRI) procedure rooms or come within the 5-G line around the scanner. The agency was responding to incidents in which the magnetic field generated by MRI equipment produced torque and displacement forces affecting pacemakers and other implantables, resulting in the tearing of soft tissue and device malfunctions. To enable patients with implanted pacemakers to take advantage of MRI procedures, Biophan Technologies Inc. (West Henrietta, NY) developed an MRI-compatible implantable device. To address materials and miniaturization issues, the firm enlisted the assistance of Valtronic (Solon, OH), a company that develops and manufactures miniature electronic components to customer specifications.

In traditional pacemaker designs, a metallic wire lead connects the pacemaker to the heart. In proximity to MRI equipment, the lead can get very hot and cause an adverse event. Biophan replaced the metal lead with a fiber-optic cable, thus eliminating this potential hazard. Having resolved the device performance issues, Biophan turned to Valtronic for help on miniaturization of the electronic components. In particular, company engineers asked their peers at Valtronic to make a miniature probe for the MRI-safe pacemaker. The major challenge, according to Valtronic director of sales and marketing Gary Pinkerton, resided in making "the probe tip small enough so that it would be superior in size to standard pacemaker leads."

The probe tip comprises an optical-fiber termination, electrode, LED, photodiode, and microprocessor. "That's where a lot of the magic happens," says Pinkerton. It's also where Valtronic worked its own magic . . . on a very small scale.

Flip Chips and Beyond

Miniature electronic components supplied by Valtronic enabled the design of a suitably sized probe tip for the implanted pacemaker.
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Gold-on-gold flip chips and 3-D chip-scale packaging (3D-CSP) are Valtronic's signature miniaturization strategies, according to Pinkerton. Flip-chip technology involves mounting raw integrated circuits facedown on a PC board, thus reclaiming the space surrounding the chips that was normally consumed by conventional packaging and leads. As initially developed by IBM, flip-chip technology was a solder-based process. Valtronic uses low-impedance gold contacts on the chips and circuit boards, bonding them by means of a proprietary nonconductive adhesive.

By combining flip chips with flexible PC board substrates, Valtronic produces 3-D chip-scale packaging, the smallest possible volume for electronic assemblies available to industry, according to the firm. 3D-CSP uses a combination of open and proprietary techniques to produce printed circuit boards that can be folded into dense electronic modules. These components achieve up to 80% size reductions compared to conventional assemblies. The technology has been used to design the electronics for a 4.5 x 4 x 3-mm, completely in-the-ear hearing aid, reportedly the world's smallest such device.

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